Regulatory Affairs Specialist

Regulatory Affairs Specialist

Take your regulatory affairs experience to the next level with an exciting opportunity supporting innovative in vitro diagnostic (IVD) products. This role offers hands-on involvement with global regulatory submissions, cross-functional collaboration, and the chance to make a meaningful impact in the clinical diagnostics industry while working with a leading life sciences organization.

Location: Hercules, CA (Onsite) Pay Rate: $40/hour Employment Type: Contract through 12/31/2026 Schedule: Day Shift

Why This Role Matters

In this role, you will help support global regulatory activities for IVD products used in clinical diagnostics. Your work will contribute to worldwide product registrations and regulatory compliance efforts, helping bring important diagnostic solutions to healthcare providers and patients.

What You'll Do

• Assemble low- to medium-complexity regulatory submissions supporting worldwide product registration change requests for IVDR • Provide regulatory support across multiple IVD product groups within clinical diagnostics • Collaborate closely with Regulatory Affairs, R&D, Quality Assurance, Planning, and Manufacturing teams • Interface daily with desktop publishers, technical writers, and regulatory specialists • Review and organize scientific and regulatory documentation to support submissions • Utilize electronic systems and databases to manage regulatory data and records • Apply analytical and problem-solving skills to support daily regulatory activities and project deadlines

What We're Looking For

• A current, up-to-date resume • Bachelor's degree in Biology or another scientific field • 6 months to 2 years of experience in IVD Regulatory Affairs • Proficiency with Microsoft Office applications including Excel, Word, PowerPoint, and Teams • Strong prioritization skills with the ability to manage multiple projects simultaneously • Excellent communication skills and ability to work effectively across departments • Highly organized with strong attention to detail and time management skills • Technical aptitude and ability to understand IVD product features and functionality • Understanding of databases and electronic document management systems • Laboratory research experience in an IVD medical device regulated environment strongly preferred • Understanding of scientific reports, risk management processes, and Quality Systems • Ability to meet compliance requirements

What's In It For You

• Competitive pay at $40/hour • Gain valuable experience supporting global IVDR regulatory submissions • Opportunity to work cross-functionally with industry professionals and subject matter experts • Expand your knowledge of clinical diagnostics and regulated medical device environments • Build experience with regulatory documentation, systems, and processes in a global organization • Develop professional skills in project management, collaboration, and regulatory compliance

Benefits for Manpower Associates (Upon Eligibility)

Upon completion of waiting period associates are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Supplemental Life Insurance
• Short Term Disability Insurance
• 401(k)